Dataset Information

Home-delivered meals for people with dementia: Which model delays nursing home placement? - Protocol for a feasibility pilot.

ABSTRACT:

Background

Home-delivered meals promote food security, socialization, and independence among homebound older adults. However, it is unclear which of the two predominant modes of meal delivery, daily-delivered vs. drop-shipped, frozen meals, promotes community living for homebound older adults with dementia. Our objective is to present the protocol for a pilot multisite, two-arm, pragmatic feasibility trial comparing the effect of two modes of meal delivery on nursing home placement among people with dementia. We include justifications for individual randomization with different consent processes and waivers for specific elements of the trial.

Methods

236 individuals with dementia on waiting lists at three Meals on Wheels programs' in Florida and Texas will be randomized to receive either: 1) meals delivered multiple times per week by a Meals on Wheels volunteer or paid driver who may socialize with and provide an informal wellness check or 2) frozen meals that are mailed to participants' homes every two weeks. We will evaluate and refine processes for recruitment and randomization; assess adherence to the intervention; identify common themes in participant experience; and test processes for linking participant data with Medicare records and nursing home assessment data. We will conduct exploratory analyses examining time to nursing home placement, the primary outcome for the larger trial.

Conclusion

This pilot will inform the follow-on large-scale, definitive pragmatic trial. In addition, the justifications for individual randomization with differing consent procedures for elements of a pragmatic trial provide a model for future trialists looking to develop ethical and feasible pragmatic studies enrolling people with dementia.

SUBMITTER: Thomas KS

PROVIDER: S-EPMC9817376 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature

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Publications

Home-delivered meals for people with dementia: Which model delays nursing home placement? - Protocol for a feasibility pilot.

Thomas Kali S KS Dosa David M DM Fisher Alison A Gadbois Emily E Harrison Jill J Hilgeman Michelle M Largent Emily A EA Lima Julie J McAuliff Katie K McCreedy Ellen E Mills Whitney W Ornstein Katherine A KA Shield Renee R RR Barron Marycela M Callaghan Shawna S Clark Kayla K Culak Chris C Faris Vinsen V Frankhauser Anita E AE Huerta Sophie S Krause Katherine K Martinez Ileana I Mayer Amanda A Rodriguez Jacqueline J Theilheimer Lucy L Truelove William W Wilson Inga I Gutman Roee R

Contemporary clinical trials 20220830

<h4>Background</h4>Home-delivered meals promote food security, socialization, and independence among homebound older adults. However, it is unclear which of the two predominant modes of meal delivery, daily-delivered vs. drop-shipped, frozen meals, promotes community living for homebound older adults with dementia. Our objective is to present the protocol for a pilot multisite, two-arm, pragmatic feasibility trial comparing the effect of two modes of meal delivery on nursing home placement among ...[more]

PMID: 36055581

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Project description:ImportanceHome-delivered meals promote food security and independence among homebound older adults. However, it is unclear which of the 2 predominant modes of meal delivery, daily-delivered vs mailed (or drop-shipped) frozen meals, promotes community living for homebound older adults with dementia.ObjectiveTo assess the risk of nursing home admission within 6 months between homebound individuals receiving daily-delivered vs drop-shipped frozen meals.Design, setting, and participantsThis pilot, multisite, 2-arm, pragmatic clinical trial included older adults with self-reported dementia on waiting lists for meals at 3 Meals on Wheels (MOW) programs in Texas and Florida between April 7 and October 8, 2021, to assess time to nursing home placement.InterventionsParticipants were randomized to receive either meals delivered by an MOW driver or frozen meals that were mailed to participants' homes every 2 weeks. Participants received their assigned intervention for up to 6 months.Main outcomes and measuresThe primary study outcome was days from randomization to a Minimum Data Set nursing home admission assessment within 6 months. Feasibility of conducting this type of study was examined by tracking enrollment, examining baseline characteristics, monitoring participants' intervention fidelity, measuring the proportion of participants linked with Centers for Medicare & Medicaid Services (CMS) data, and analyzing the primary study outcome.ResultsAmong 325 eligible participants who were randomized, 243 enrolled in the study (mean [SD] age, 81 [8.0] years; 152 (62.6%) were female): 128 to the daily-delivered meals group and 115 to the drop-shipped frozen meals group; 119 participants (49.0%) lived alone. Among the total participants enrolled, 227 (93.4%) were linked deterministically to their CMS data; probabilistic methods were used to link the remaining 16 participants (6.6%). At 6 months from randomization, 160 participants (65.8%) were still receiving meals, and 25 (10.1%; 95% CI, 6.3%-14.0%) were admitted to a nursing home. After adjusting for sex, race and ethnicity, age, program, and living arrangement and the use of death as a censoring event, the adjusted log hazard ratio of nursing home placement between daily-delivered and drop-shipped frozen meals was -0.67 (95% CI, -1.52 to 0.19).Conclusions and relevanceThis pilot randomized clinical trial demonstrated the feasibility of enrolling participants with self-reported dementia on waiting lists at MOW programs, linking their data, and evaluating outcomes. While this pilot study was not powered to detect meaningful, statistically significant differences in nursing home placement, its feasibility and initial results warrant exploration in a follow-on, adequately powered trial.Trial registrationClinicalTrials.gov Identifier: NCT04850781.

Project description:BackgroundAmong older adults, food insecurity is associated with poor health status and health outcomes; people living with dementia (PLWD) are at increased risk for insecurity. Approaches to addressing food insecurity among homebound older adults include two modes of home-delivered meals: (1) meals delivered daily to participants' homes by a volunteer or paid driver who socializes with the client or (2) frozen meals that are mailed to participants' homes. Research has not examined benefits of these meals for PLWD or their caregivers nor compared the effectiveness of these two approaches in reducing food insecurity. The objective of this study was to test the processes for recruiting and engaging in qualitative research with PLWD and caregivers in an effort to understand the context, implementation, and mechanisms of impact by which relationships between meal delivery and outcomes may be achieved in preparation for a larger, follow-on study.MethodsThis is a qualitative sub-study of a pilot, multisite, two-arm pragmatic feasibility trial comparing the effect of two modes of meal delivery on nursing home placement among 243 PLWD. In this sub-study, we tested recruitment and enrollment procedures and piloted interview guides among a subset of participants and caregivers.ResultsWe recruited and conducted interviews with nine PLWD and seven caregivers. In testing the informed consent process, all participants were able to consent to be interviewed, and PLWD all demonstrated capacity to consent. We successfully used a cognitive screener to obtain scores of cognitive impairment for PLWD and observed scores indicating a broad range of function. Our interview guides successfully resulted in information about the context, implementation, and mechanisms of impact for meal delivery during the pilot.ConclusionsIn addition to establishing feasibility for the future trial, the substantive findings identified through the qualitative interviews provide an initial understanding of the contextual factors for meal delivery and the potential mechanisms of impact across meal delivery types that warrant further examination in a full-scale trial. Findings from our study provide crucial pilot data to support a follow-on trial to understand how to address food insecurity among PLWD.Name of the registryClinicalTrials.gov TRIAL REGISTRATION: NCT04850781 DATE OF REGISTRATION: April 20, 2021, retrospectively registered https://clinicaltrials.gov/ct2/show/NCT04850781.

Project description:Background: Setting up a home-delivered meal service often allows older people suffering from physical and/or cognitive disabilities to stay at home. However, older people who delegate their food activities (food purchasing, cooking…) have been reported to have a worse nutritional status than people who take care of their food activities. In this context, we will conduct a systematic review of all studies related to the nutritional issue in home-delivered meal older recipients. Methods: In June 2020, we searched 3 databases (Pubmed, Web of Science, EMBASE) to identify studies from all years on older adults at home and receiving home-delivered meal services (population). The following outcomes were considered: nutritional status (Body Mass Index, weight, undernutrition) and nutritional intake. Any nutritional intervention, comparator, and study design were relevant for inclusion. Results: Forty-eight original studies met the inclusion criteria, most of them being published after the year 2000 (n = 34) and undertaken in the USA (n = 32). The selection includes 30 cross-sectional and 18 longitudinal studies. The main findings of this review are the following: (1) home-delivery meal older recipients are at high risk of undernutrition; (2) providing home-delivery meals may improve the nutritional status and nutrient intake; (3) this improvement is even higher when the home-delivery meal service is improved, for instance by providing dietetic counseling or adding supplementary snacks/meals or enriched food. However, even an improved service does not allow all the older recipients meeting their recommended nutritional allowance. Conclusion: This review reveals a need to further develop strategies allowing home-delivery meal older recipients to fulfill their nutritional needs. From a methodological point of view, there is a need to describe in more detail the home-delivered services provided to studies' participants to better consider meal frequency and meal content in the results.

Project description:Background In patients with heart failure (HF), malnutrition and dietary sodium excess are common and may worsen outcomes. No prior studies have provided low-sodium, nutritionally complete meals following HF hospitalization. Methods and Results The GOURMET-HF study (Geriatric Out-of-Hospital Randomized Meal Trial in Heart Failure) randomized patients discharged from HF hospitalization to 4 weeks of home-delivered sodium-restricted Dietary Approaches to Stop Hypertension meals (DASH/SRD; 1500 mg sodium/d) versus usual care. The primary outcome was the between-group change in the Kansas City Cardiomyopathy Questionnaire summary score from discharge to 4 weeks postdischarge. Additional outcomes included changes in the Kansas City Cardiomyopathy Questionnaire clinical summary score and cardiac biomarkers. All patients were followed 12 weeks for death/all-cause readmission and potential diet-related adverse events (symptomatic hypotension, hyperkalemia, acute kidney injury). Sixty-six patients were randomized 1:1 at discharge to DASH/SRD versus usual care (age, 71±8 years; 30% female; ejection fraction, 39±18%). The Kansas City Cardiomyopathy Questionnaire summary score increased similarly between groups (DASH/SRD 46±23-59±20 versus usual care 43±19-53±24; P=0.38), but the Kansas City Cardiomyopathy Questionnaire clinical summary score increase tended to be greater in DASH/SRD participants (47±22-65±19 versus 45±20-55±26; P=0.053). Potentially diet-related adverse events were uncommon; 30-day HF readmissions (11% versus 27%; P=0.06) and days rehospitalized within that timeframe (17 versus 55; P=0.055) trended lower in DASH/SRD participants. Conclusions Home-delivered DASH/SRD after HF hospitalization appeared safe in selected patients and had directionally favorable effects on HF clinical status and 30-day readmissions. Larger studies are warranted to clarify the effects of postdischarge nutritional support in patients with HF. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT02148679.

Project description:BackgroundMedication regimens in nursing home (NH) residents with severe dementia should be frequently reviewed to avoid inappropriate medication, overtreatment and adverse drug events, within a comfort care approach. This study aimed at testing the feasibility of an interdisciplinary knowledge exchange (KE) intervention using a medication review guidance tool categorizing medications as either "generally", "sometimes" or "exceptionally" appropriate for NH residents with severe dementia.MethodsA quasi-experimental feasibility pilot study with 44 participating residents aged 65 years or over with severe dementia was carried out in three NH in Quebec City, Canada. The intervention comprised an information leaflet for residents' families, a 90-min KE session for NH general practitioners (GP), pharmacists and nurses focusing on the medication review guidance tool, a medication review by the pharmacists for participating residents with ensuing team discussion on medication changes, and a post-intervention KE session to obtain feedback from team staff. Medication regimens and levels of pain and of agitation of the participants were evaluated at baseline and at 4 months post-intervention. A questionnaire for team staff explored perceived barriers and facilitators. Statistical differences in measures comparing pre and post-intervention were assessed using paired t-tests and Cochran's-Q tests.ResultsThe KE sessions reached 34 NH team staff (5 GP, 4 pharmacists, 6 heads of care unit and 19 staff nurses). Forty-four residents participated in the study and were followed for a mean of 104 days. The total number of regular medications was 372 pre and 327 post-intervention. The mean number of regular medications per resident was 7.86 pre and 6.81 post-intervention. The odds ratios estimating the risks of using any regular medication or a "sometimes appropriate" medication post-intervention were 0.81 (95% CI: 0.71-0.92) and 0.83 (95% CI: 0.74-0.94), respectively.ConclusionA simple KE intervention using a medication review guidance tool categorizing medications as being either "generally", "sometimes" or "exceptionally" appropriate in severe dementia was well received and accompanied by an overall reduction in medication use by NH residents with severe dementia. Levels of agitation were unaffected and there was no clinically significant changes in levels of pain. Staff feedback provided opportunities to improve the intervention.

Dataset Information

Home-delivered meals for people with dementia: Which model delays nursing home placement? - Protocol for a feasibility pilot.

Background

Methods

Conclusion

Publications

Home-delivered meals for people with dementia: Which model delays nursing home placement? - Protocol for a feasibility pilot.

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